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IT Systems Validator
2 weeks ago
We are seeking a skilled professional to fill the role of IT CSV Engineer. The successful candidate will be responsible for validating lab systems in QCL Labs and Manufacturing Operations.
Key Accountabilities:
- Lead lab equipment validation projects from software installation to business release
- Plan and prioritize CSV activities to meet project deadlines
- Create comprehensive computer system validation documentation, adhering to site procedures and GMP guidelines
- Examine software release notes for relevance
Essential Skills:
- At least 3 years of experience supporting and validating lab equipment, updating documentation, and system testing
- Familiarity with 21CFR Part 11 regulations and data integrity principles
- Strong analytical and problem-solving skills, with the ability to identify software gaps
- Effective communication and relationship-building skills